Six-month outcomes of a Three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. Versius robotic radical prostatectomy: (the COMPAR-P trial)

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Abstract Background: To compare postoperative, oncological, and patient-reported outcomes of robot-assisted radical prostatectomy (RARP) performed with three CE-marked robotic platforms: Da Vinci Xi, Hugo RAS, and Versius. Methods: The COMPAR-P trial is a prospective, monocentric, post-market study conducted at the Azienda Ospedaliera Universitaria Integrata of Verona, Italy (ClinicalTrials.gov NCT05766163). From March 2023, 150 patients with organ-confined prostate cancer were consecutively enrolled and allocated to undergo RARP with Da Vinci Xi (n = 50), Hugo RAS (n = 50), or Versius (n = 50). Two high-volume robotic surgeons performed all procedures, experienced with Da Vinci but naïve to Hugo RAS and Versius before trial initiation. Surgical technique, perioperative protocols, and follow-up were standardized across cohorts. Outcomes at 6 months included serum PSA, complications (Clavien–Dindo classification), late sequelae (> 90 days), and health-related quality of life (SF-36 and UCLA-PCI questionnaires). Longitudinal analyses used linear mixed-effects models. Results: Baseline demographics and disease characteristics were comparable across groups. At 6 months, PSA was undetectable in most patients, with no significant intergroup differences. Complication rates and late sequelae were low and evenly distributed. Questionnaire completion exceeded 90% at all time points. No significant long-term differences emerged in most SF-36 and UCLA-PCI domains. However, at 1 month, Hugo RAS and Versius patients reported lower Sexual Function scores than Da Vinci (–20 and − 28 points, respectively), and Versius patients reported lower Sexual Bother scores (–25 points, all p < 0.05). These differences disappeared at 3 and 6 months. Hugo RAS patients showed a temporary advantage in Physical Functioning at 1 month (+ 17 points vs Da Vinci). Conclusions: Da Vinci, Hugo RAS, and Versius showed equivalent safety, oncological outcomes, and medium-term patient-reported results in RARP. Early functional differences were transient and resolved over time. Surgical expertise, rather than the type of platform, appears to be the primary determinant of outcomes.
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Methods: The COMPAR-P trial is a prospective, monocentric, post-market study conducted at the Azienda Ospedaliera Universitaria Integrata of Verona, Italy (ClinicalTrials.gov NCT05766163). From March 2023, 150 patients with organ-confined prostate cancer were consecutively enrolled and allocated to undergo RARP with Da Vinci Xi (n = 50), Hugo RAS (n = 50), or Versius (n = 50). Two high-volume robotic surgeons performed all procedures, experienced with Da Vinci but naïve to Hugo RAS and Versius before trial initiation. Surgical technique, perioperative protocols, and follow-up were standardized across cohorts. Outcomes at 6 months included serum PSA, complications (Clavien–Dindo classification), late sequelae (> 90 days), and health-related quality of life (SF-36 and UCLA-PCI questionnaires). Longitudinal analyses used linear mixed-effects models. Results: Baseline demographics and disease characteristics were comparable across groups. At 6 months, PSA was undetectable in most patients, with no significant intergroup differences. Complication rates and late sequelae were low and evenly distributed. Questionnaire completion exceeded 90% at all time points. No significant long-term differences emerged in most SF-36 and UCLA-PCI domains. However, at 1 month, Hugo RAS and Versius patients reported lower Sexual Function scores than Da Vinci (–20 and − 28 points, respectively), and Versius patients reported lower Sexual Bother scores (–25 points, all p < 0.05). These differences disappeared at 3 and 6 months. Hugo RAS patients showed a temporary advantage in Physical Functioning at 1 month (+ 17 points vs Da Vinci). Conclusions: Da Vinci, Hugo RAS, and Versius showed equivalent safety, oncological outcomes, and medium-term patient-reported results in RARP. Early functional differences were transient and resolved over time. Surgical expertise, rather than the type of platform, appears to be the primary determinant of outcomes. DaVinci Hugo RAS Versius Radical prostatectomy Robotic surgery Figures Figure 1 Figure 2 1. Introduction In the past few years, novel robotic platforms have been introduced, potentially increasing competition in the market, lowering the cost of robotics, and potentially expanding the number of patients benefiting from surgery performed via a robotic approach [ 1 ]. The Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA), has long been the gold standard in robotic-assisted surgery, dominating the field with its surgeon-friendly interface. Since its introduction, it has become synonymous with minimally invasive prostatectomy, offering three-dimensional visualization, enhanced dexterity with wristed instruments, and ergonomic control for surgeons. The Versius (CMR Surgical Ltd, Cambridge, UK) and the Hugo RAS (Medtronic, Minneapolis, MN, USA) systems have emerged as other frontrunners in robotic prostatectomy after receiving the CE mark approval in 2021 and 2019. These platforms introduced novel features such as modular robotic arms and an open console architecture, promising to address eventual limitations associated with Da Vinci [ 2 – 4 ]. These systems have had a patchy penetration among institutions, so a few publications have appeared, generally represented by retrospective single-arm non-comparative studies [ 5 ]. There is an imperative need for a comprehensive comparative analysis between the two robotic platforms. Understanding the nuanced differences in efficacy, ergonomics, cost-effectiveness, and learning curves is essential for surgeons, healthcare institutions, and patients. Accordingly, we promoted a prospective study to perform a head-to-head comparison of the three platforms CE-marked for RARP. The present paper reports granular data of the patients enrolled in the three arms: Da Vinci versus Hugo RAS versus Versius RARP, to compare the postoperative and patient-reported outcomes of the RARP performed with these three platforms. 2. Materials and Methods The COMPAR-P trial (Comparison of Outcomes of Multiple Platforms for Assisted Robotic Surgery - Prostate) is a monocentric, post-market investigation promoted by the Azienda Ospedaliera Universitaria Integrata (A.O.U.I.) of Verona, Italy [ 6 ]. It secured approval from the local ethical committee (4038CESC) and underwent registration on ClinicalTrials.gov (NCT05766163). The study was performed in accordance with the Declaration of Helsinki. Enrollment commenced in March 2023. Patients diagnosed with organ-confined prostate cancer and deemed suitable for RARP at our department were assigned to one of the evaluated platforms until cohorts of 50 consecutive cases were completed. Every patient wishing to participate in the study provided signed informed consent. The operating room personnel underwent intensive 3-day training at the ORSI Academy in Melle, Belgium. Two console surgeons (AA and VD), with prior experience exceeding 1000 and 500 da Vinci RARP interventions, respectively, conducted all the procedures. Importantly, none had performed any clinical procedure with the Hugo RAS or the Versius platforms before recruitment for this study started. Three additional surgeons, well-versed in robotic assistance (RB, RR, and AV), participated as table assistants. The anesthesiologic protocol and patient positioning (supine position, legs together and extended, 25° Trendelenburg) remained consistent regardless of the platform used. Specific adaptations in port placement relative to the Da Vinci system were applied according to the platform used, as previously described [ 7 , 8 ]. Consistency was maintained across platforms concerning insufflation and aspiration systems, robotic instruments (monopolar scissor, Maryland bipolar forceps, fenestrated grasp, and needle-driver), assistant instruments, sutures, and clips. The surgical technique was reproduced identically, regardless of the platform used. Depending on clinical data, an intra-, inter-, or extra-fascial anterior antegrade dissection was performed. The decision to perform a lymph-node dissection (LND) was based on the calculated risk of lymph-nodal invasion, determined by nomograms, and followed an extended template [ 9 ]. The postoperative course was managed following the Institutional standard practice in all cases [ 9 ]. The present study aimed to evaluate, with a 6-month follow-up, the differences among da Vinci vs. Hugo RAS vs. Versius in terms of: serum prostate-specific antigen (PSA, considered undetectable when 3); postoperative sequelae occurring beyond 90 days (monitored up to 180 days postoperatively); patients’ health-related quality of life (assessed by administering the Italian-validated versions of the SF-36 and University of California Los Angeles Prostate Cancer Index [UCLA-PCI] questionnaires [ 10 , 11 ]). De-identified data were systematically collected in a Research Electronic Data Capture (REDCap) dataset throughout the surgical procedures by an assigned investigator who did not participate in the surgeries. Access to REDCap was restricted to a specific password-coded computer securely stored within a locker. The password underwent periodic changes and was exclusively managed by the involved investigators. 2.1. Statistical Analysis All statistical analyses were conducted per international guidelines for clinical research reporting [ 12 ]. The sample size was determined based on study feasibility, resulting in 50 patients per cohort. The distribution of continuous variables was assessed using the Shapiro–Wilk test and visual inspection (histograms and Q–Q plots). Normally distributed data were summarized as mean ± standard deviation (SD), whereas non-normally distributed variables were presented as median and interquartile range (IQR, 25th − 75th percentile). Categorical variables were described as counts and percentages. Between-group comparisons were performed using the Student’s t-test for normally distributed continuous variables and the Mann–Whitney U test for nonparametric variables. Differences in categorical variables were analyzed using Pearson’s chi-square test or Fisher’s exact test when expected counts were < 5. Longitudinal outcomes (SF-36 and UCLA-PCI scores) were analyzed using linear mixed-effects models with random intercepts for patients. Fixed effects included robotic platform, time, and the platform × time interaction. Adjustment variables were age at surgery, baseline questionnaire scores, preoperative serum PSA levels, and prostate volume. Missing data were assumed to be random, and no imputation methods were adopted. The domain scores were calculated excluding the missing items. The domain score was not calculated if more than 50% of the items were missing. All tests were two-sided, with statistical significance set at P < 0.05. Analyses were performed using Stata version 18.0 (StataCorp LLC, College Station, TX, USA). Key commands included: swilk, histogram, ttest, tabstat, ranksum, tabulate, chi2, mixed, contrast, and margins. 3. Results During the study period, 150 patients were operated on, specifically 50 patients for each platform under investigation. The operated patients’ baseline demographic and disease characteristics were not statistically different when comparing platform versus platform, respectively [ 7 , 8 ]. The number of patients with a measurable PSA at six-month follow-up after surgery was 2 (4%) in both the Da Vinci and Hugo RAS groups, and 4 (8%) in the Versius group, with no statistically significant differences ( Supplementary Table 1 ). Both minor and major complications and postoperative sequelae occurring beyond 90 days after surgery are detailed in Table 1 , stratified by platform. Table 1 Details of Complications, Sequelae, and Management. Da Vinci® No. events = 17 Event Diagnosis time (postoperative days) Management 1. Incisional hernia 2. Edema of the lower limbs 3. Desaturation (90% SpO 2 ) 4. Leakage from the vesicourethral anastomosis (4x) 5. Orchiepididymitis (2x) 6. Myocardial Infarction ≤ 30 days 1. No current management; hernia repair may be considered if needed. 2. Wearing compression stockings 3. Chest X-ray performed, and antibiotic therapy initiated 4. Maintenance/repositioning of the urinary catheter 5. antibiotic therapy initiated 6. PTCA 1. Orchiepididymitis 2. Incisional hernia (2x) 3. Fluid collection at the midline wound 4. Leakage from the vesicourethral anastomosis (2x) > 30, ≤ 90 days 1. antibiotic therapy initiated 2. No current management; hernia repair may be considered if needed. 3. Antibiotic therapy initiated 4. Repositioning of the urinary catheter 1. Urethral stenosis with retention > 90, ≤ 180 days 1. Placement of suprapubic cystostomy and urethrotomy Hugo RAS™ No. events = 18 1. Urinary retention 2. Peritoneal effusion 3. Pulmonary embolism originating from thrombosis of the left common and deep femoral venous axis 4. Urinary Tract Infection 5. Bilateral orchitis 6. Leakage from the vesicourethral anastomosis with catheterization 7. Abdominal hemorrhage 8. Pulmonary embolism with intensive care unit admission ≤ 30 days 1. Catheterization, antibiotic therapy, and cystography prior to catheter removal 1. Penile tumescence 2. Venous ooze from the wound edge 3. Umbilical hernia (2x) 4. Difficulty with adduction of the left thigh 5. Pulmonary embolism originating from thrombosis of the left deep femoral and common femoral veins 6. Recurrent urinary retention > 30, ≤ 90 days 1. Conservative management, with spontaneous resolution 2. Suture placed after local anesthetic spray 3. No current management; hernia repair may be considered if needed. 4. Electromyography performed: finding of chronic axonal injury of the left obturator nerve: on neurological indication, physiotherapy initiated. 5. Rivaroxaban initiated 6. Cystography and flexible urethrocystoscopy performed; catheter replaced 1. Lymphocele 2. Lymphedema of the right lower limb, involving the inguinal region 3. Recurrent urinary retention > 90, ≤ 180 days 1. Conservative management 2. Lymphatic drainage massages performed 3. Cystography and flexible urethrocystoscopy performed; catheter replaced Versius® number of events = 24 1. Urinary tract infection 2. Hematuria and pelvic pain in the absence of fever; tenderness at the perineum and right hemiscrotum; right epididymis slightly tender, likely reflecting inflammatory sequelae 3. Findings of scrotal edema, pollakiuria, and dysuria 4. Leakage from the vesicourethral anastomosis (2x) 5. Abdominal pain 6. Urosepsis 7. Fever (urine and blood cultures negative) 8. Abdominal distension (globular, non-tender abdomen), mild tenderness in the right flank. 9. Scrotal edema 10. Initial lymphedema of the right lower limb, involving the inguinal region 11. Pain localized to the perineum in the seated position ≤ 30 days 1. Antibiotic therapy initiated 2. Started dietary supplement containing bromelain, papain, and fungal proteases 3. Urine culture showed no growth. Conservative management 4. Maintenance/repositioning of the urinary catheter 5. Analgesics initiated 6. Antibiotic therapy initiated 7. Antibiotic therapy initiated 8. Conservative management 9. Conservative management, with spontaneous resolution 10. Lymphatic drainage massages performed 11. Local ice therapy applied 1. Urinary tract infection (3x) 2. Penile tumescence 3. Persistent pain symptoms at the level of the coccyx, perineal area, and penile shaft. 4. Dysuria 5. Lower urinary tract symptoms with weak stream, urinary urgency, and urge incontinence 6. Lymphocele 7. Severe erectile dysfunction > 30, ≤ 90 days 1. Antibiotic therapy initiated 2. Conservative management, with spontaneous resolution 3. Coccygeal massages of limited success; use of analgesic 4. Cystography and flexible urethrocystoscopy with diagnosis of anastomosis stricture 5. Negative urine culture. Urodynamic diagnosis of hypocontractile and overactive bladder 6. Conservative management 7. penile doppler ultrasound: hemodynamic parameters consistent with erectile dysfunction due to veno-occlusive dysfunction 1. Acute urinary retention associated with pain and vomiting 2. Dysuria 3. Lymphedema of the right lower limb > 90, ≤ 180 days 1. Placement of suprapubic cystostomy 2. Endoscopic management of a diagnosed stenosis of the vesicoureteral anastomosis. 3. Wearing compression stockings All patients completed the SF-36 and UCLA-PCI questionnaires at baseline (response rate 100%). Supplementary Table 2 includes the questionnaire scores at baseline, derived from the patients’ raw responses, before applying the statistical model. For Da Vinci, Hugo RAS, and Versius, the response rates were 100, 92, and 98% at 1-month follow-up, 98, 98, and 94% at 3 months, and 100, 94, and 94% at the 6-month monitoring visit, respectively. The effects of the type of robot used (Da Vinci, Hugo RAS, Versius) on the 0–100 response scores of the SF-36 and UCLA-PCI questionnaires at different study time points (baseline/surgery time, follow-up at 1, 3, and 6 months) were analyzed using a mixed model with robot × time interaction (detailed in Supplementary Table 3 ). Comparisons between robotic groups at each time point did not show statistically significant differences for most domains analyzed (p > 0.05). However, the interaction analysis revealed some significant effects: on the UCLA-PCI questionnaire, the Hugo RAS group showed a mean difference of − 19.73 points (p = 0.03, 95% CI [–37.53; − 1.93]), indicating a significant reduction in the Sexual Function domain score compared with the Da Vinci group. The Versius group also showed a significant mean decrease of − 27.7 points (p = 0.001, 95% CI [–43.51; − 11.88]) in the Sexual Function score compared with the Da Vinci group at 1-month post-surgery. Finally, again at 1 month postoperatively, the Versius group showed a mean difference of − 25.16 points (p = 0.026, 95% CI [–47.35; − 2.97]), suggesting a significant reduction in the Sexual Bother domain score compared with the Da Vinci group. As for the SF-36 questionnaire, the only significant difference was observed in the Physical Functioning domain, where Hugo RAS, at 1-month post-surgery, showed an average score of + 17.10 points higher compared with the Da Vinci group (Graphical representations are shown in Fig. 1 and Fig. 2 ). 4. Discussion With the growing diversification of the global surgical robotics ecosystem, multiple platforms are becoming increasingly common. This raises the question of whether these systems differ in performance and cost. Several comparative studies have addressed this issue, but most available evidence is retrospective and of low quality. While some systematic reviews have attempted to synthesize the data, significant heterogeneity limits the strength of their conclusions [ 2 – 4 , 13 ]. These reviews suggest that the platforms are broadly comparable regarding safety, functional outcomes, and oncologic efficacy in cancer surgery. To our knowledge, ours is the first prospective study to compare robotic prostatectomy across three platforms: Da Vinci Xi, Hugo RAS, and Versius. In the context of an oncological surgical intervention, such as RARP, it is reassuring that—despite the relatively small sample size and limited follow-up—no significant differences were observed between patients operated with different robotic platforms regarding postoperative PSA. Six months after surgery, most patients had undetectable PSA values, regardless of the platform used, suggesting that the oncological safety of the procedure is preserved across technologies. Most complications were minor and captured within the hyper-controlled trial setting. Interesting in the present work is the description of late postoperative sequelae, recorded between 90 days and the 6-month follow-up visit. These events were anecdotal in nature and comparable across platforms. Perhaps the most relevant findings come from the analysis of patient-reported outcomes. One of the main strengths of this prospective study lies in the granularity of adverse event reporting, both in the early and mid-term, but especially in the systematic collection of validated questionnaires. While radical prostatectomy is effective for cancer control, it is often associated with quality-of-life issues related to erectile dysfunction and urinary incontinence. Therefore, integrating patient-reported outcomes into clinical care is crucial to ensure comprehensive and effective treatment [ 14 ]. The response rate of our investigation was remarkably high, exceeding 90% and often approaching 100% at all evaluated time points, providing robustness to these results. From a global perspective, comparisons between robotic systems did not reveal significant differences in most questionnaire domains. However, some differences emerged when focusing on specific outcomes at the 1-month time point. On the UCLA-PCI questionnaire, the Hugo RAS (–20 points) and the Versius platform (–28 points) showed a significant reduction in the Sexual Function domain compared with Da Vinci. In the Sexual Bother domain, Versius also performed worse than Da Vinci (–25 points). The fact that Versius performed worse in the immediate postoperative period in terms of perceived sexual function contrasts, to some extent, with the high rate of positive surgical margins (40%), with a p-value approaching significance not in comparison with Da Vinci, but rather with Hugo RAS. Although baseline disease characteristics did not differ between groups, and nerve-sparing techniques were applied with comparable frequency across platforms, there may be something intrinsic to the console vision that could influence dissection. While this cannot be stated with certainty based on our data, it is certainly a finding that cannot be overlooked. That said, this difference in margin status did not translate into variations in the proportion of patients achieving undetectable PSA during follow-up. On the other hand, it is essential to underline that these differences were limited to the 1-month follow-up and disappeared at subsequent 3- and 6-month evaluations, suggesting only a transient early effect. On the SF-36 questionnaire, the only significant difference was observed in the Physical Functioning domain, where Hugo RAS patients scored on average 17 points higher than Da Vinci patients at 1 month. While this result is more difficult to interpret, one possible explanation may relate to differences in ergonomics, port placement, or convalescence dynamics, which could have temporarily influenced patients’ perceived ability to perform daily activities. We cannot comment on this further. Once again, however, these differences resolved at later follow-ups, reinforcing the notion of equivalence in the medium term. Moreover, although some estimates showed numerically potentially relevant differences, the wide confidence intervals suggest that the study may be underpowered to detect significant differences. Further analyses with larger samples may be needed to confirm these trends. Overall, compared with previously published experiences that have focused mainly on perioperative aspects such as docking time or operative duration [ 2 – 4 , 15 ], our study provides a broader and more detailed picture. Data collection was prospective, with balanced cohorts and without patient selection, and follow-up was particularly rigorous, extending to 6 months. The findings support the conclusion that robotic platforms are equivalent in terms of both safety (comparable complication profiles) and oncological efficacy (as indicated by undetectable PSA rates). Ultimately, our results reinforce the notion that surgical outcomes depend less on the type of robotic system used and more on the surgeon’s expertise and technique [ 16 ]. Notably, the procedures in this study were performed by high-volume robotic surgeons with extensive Da Vinci experience, who nonetheless achieved comparable results already within their first 50 cases using the alternative platforms [ 17 ]. Among the multitude of data analyzed, the only signal suggesting a potential “inferiority” of Hugo RAS and Versius concerned early patient-reported sexual function. However, given that these differences were limited to the first postoperative month and no longer evident by 3 and 6 months, their clinical significance remains debatable. A plausible interpretation is that the Da Vinci platform may initially allow more refined nerve-sparing, possibly because surgeons are more familiar with its instrumentation and energy settings, thereby reducing the risk of injury to the neurovascular bundles—although this remains only a hypothesis. Over time, recovery mitigates these differences. In summary, this prospective study demonstrates that different robotic platforms can achieve equivalent results in terms of oncological efficacy, safety, and medium-term patient-reported outcomes. The transient differences observed in some functional domains at 1 month should be interpreted with caution, and further long-term and multicenter data will be valuable to confirm these findings. Declarations Conflicts of interest The authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript. Fundings Regione Veneto (CriTE) – 21/09/2022 rif. 434224 (prot. Gen. 56613/2022). § List of Contributors : University of Verona Residency Program in Urology Mariana Finocchiaro, Luca Rahmati, Mattia Ronca, Michele Aloe, Peres Fokana Pongmoni, Andrea Franceschini, Antonio Raiti, Endri Toska, Vincenzo Vetro, Francesco Artoni, Alberto Baielli, Claudio Brancelli, Sonia Costantino, Piero Fracasso, Francesca Fumanelli, Francesca Montanaro, Iolanda Palumbo, Greta Pattenuzzo, Luca Roggero, Michele Boldini, Davide Brusa, Giovanni Corghi, Lorenzo De Bon, Francesco Ditonno, Lorenzo Pierangelo Treccani References Farinha R, Puliatti S, Mazzone E, et al. Potential contenders for the leadership in robotic surgery. J Endourol 2022;36:317–26. https://doi.org/10.1089/end.2021.0321. Ficarra V, Rossanese M, Giannarini G, Longo N, Viganò S, Russo D, Sorce G, Simonato A, Bartoletti R, Crestani A, Di Trapani E. Evaluation of Clinical Research on Novel Multiport Robotic Platforms for Urological Surgery According to the IDEAL Framework: A Systematic Review of the Literature. Eur Urol Open Sci. 2024 Jul 18;67:7-25. doi: 10.1016/j.euros.2024.06.014. Leang YJ, Kong JCH, Mosharaf Z, Hensman CS, Burton PR, Brown WA. Emerging multi-port soft tissue robotic systems: a systematic review of clinical outcomes. J Robot Surg. 2024 Mar 30;18(1):145. doi: 10.1007/s11701-024-01887-w. Reitano G, Tumminello A, Ghaffar U, Saggionetto G, Taverna A, Mangiacavallo F, Ahmed ME, Basourakos SP, Carletti F, Minardi D, Iafrate M, Morlacco A, Betto G, Karnes RJ, Moro FD, Zattoni F, Novara G. Perioperative, Oncological, and Functional Outcomes of New Multiport Robotic Platforms in Urology: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2025 Mar 3;74:44-70. doi: 10.1016/j.euros.2025.02.003. Salkowski M, Checcucci E, Chow AK, Rogers CC, Adbollah F, Liatsikos E, Dasgupta P, Guimaraes GC, Rassweiler J, Mottrie A, Breda A, Crivellaro S, Kaouk J, Porpiglia F, Autorino R. New multiport robotic surgical systems: a comprehensive literature review of clinical outcomes in urology. Ther Adv Urol. 2023 Jun 5;15:17562872231177781. doi: 10.1177/17562872231177781. Veccia A, Malandra S, Montanaro F, Pettenuzzo G, Bravi CM, Caslini VV, et al. Comparison of outcomes of multiple platforms for assisted robotic-prostatectomy: rationale and design. Minerva Urol Nephrol 2023;75:540–2. Antonelli A, Veccia A, Malandra S, Rizzetto R, De Marco V, Baielli A, Franceschini A, Fumanelli F, Montanaro F, Palumbo I, Pettenuzzo G, Roggero L, Angela Cerruto M, Bertolo R; Collaborators. Intraoperative Performance of DaVinci Versus Hugo RAS During Radical Prostatectomy: Focus on Timing, Malfunctioning, Complications, and User Satisfaction in 100 Consecutive Cases (the COMPAR-P Trial). Eur Urol Open Sci. 2024 Apr 4;63:104-112. doi: 10.1016/j.euros.2024.03.013. Antonelli A, Veccia A, Malandra S, Rizzetto R, Bianchi A, Franceschini A, et al. First prospective comparison between Versius and DaVinci Xi for robotic radical prostatectomy: focus on operative room setup, surgical timing, troubleshooting, and surgeon satisfaction (COMPAR-P Trial). Minerva Urol Nephrol. 2025 Oct;77(5):655-663. doi: 10.23736/S2724-6051.25.06514-0. https://uroweb.org/guidelines/prostate-cancer Last access on Sept 16 th 2025. Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 1998;51:1025–36. Gacci M, Livi L, Paiar F, Detti B, Litwin MS, Bartoletti R, et al. Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index. Urology 2005;66:338–43. Assel M, Sjoberg D, Elders A, et al. Guidelines for reporting of statistics for clinical research in urology. BJU Int 2019; 123: 401-10. Pal A, Gamage R. Robotic abdominopelvic surgery: a systematic review of cross-platform outcomes. J Robot Surg. 2024 Oct 29;18(1):386. doi: 10.1007/s11701-024-02144-w. Bakalis VI. Evaluating Quality of Life of Prostate Cancer Patients After Radical Prostatectomy. Cureus. 2025 Mar 3;17(3):e79973. doi: 10.7759/cureus.79973. Ditonno F, Pettenuzzo G, Montanaro F, De Bon L, Costantino S, Toska E, et al. Head-to-head comparison of DaVinci and Hugo™ RAS robotic platforms for robot-assisted radical prostatectomy: a systematic review and meta-analysis of comparative studies. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):309-317. doi: 10.1038/s41391-024-00908-x. Epub 2024 Oct 15. Studer UE. The surgeon makes the difference, not the instrument used. Eur Urol 2015;67:1051–2. Antonelli A, Veccia A, Malandra S, Rizzetto R, Artoni F, Fracasso P, Fumanelli F, Palumbo I, Raiti A, Roggero L, Treccani LP, Vetro V, DE Marco V, Porcaro AB, Cerruto MA, Brunelli M, Bertolo R; Residency Program in Urology at the University of Verona. Outcomes of da Vinci® versus Hugo RAS® radical prostatectomy: focus on postoperative course, pathological findings, and patients' health-related quality of life after 100 consecutive cases (the COMPAR-P prospective trial). Minerva Urol Nephrol. 2024 Oct;76(5):596-605. doi: 10.23736/S2724-6051.24.05928-7. Additional Declarations No competing interests reported. Supplementary Files SupplementaryTable1.docx SupplementaryTable2.docx SupplementaryTable3.docx NCT05766163.csv Cite Share Download PDF Status: Published Journal Publication published 19 Mar, 2026 Read the published version in Journal of Robotic Surgery → Version 1 posted Editorial decision: Revision requested 04 Feb, 2026 Reviewers agreed at journal 04 Feb, 2026 Reviews received at journal 04 Feb, 2026 Reviews received at journal 04 Feb, 2026 Reviewers agreed at journal 04 Feb, 2026 Reviews received at journal 03 Feb, 2026 Reviewers agreed at journal 03 Feb, 2026 Reviewers agreed at journal 03 Feb, 2026 Reviewers agreed at journal 02 Feb, 2026 Reviewers agreed at journal 02 Feb, 2026 Reviewers invited by journal 02 Feb, 2026 Editor assigned by journal 30 Jan, 2026 Submission checks completed at journal 30 Jan, 2026 First submitted to journal 28 Jan, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-8721999","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":585275185,"identity":"971c3262-0651-4f15-b07b-47daac148a06","order_by":0,"name":"Alessandro Antonelli","email":"","orcid":"","institution":"University of Verona","correspondingAuthor":false,"prefix":"","firstName":"Alessandro","middleName":"","lastName":"Antonelli","suffix":""},{"id":585275186,"identity":"87de9310-5039-486a-8b14-c438fe4335b7","order_by":1,"name":"Alessandro Veccia","email":"","orcid":"","institution":"Azienda Ospedaliera Universitaria Integrata Verona","correspondingAuthor":false,"prefix":"","firstName":"Alessandro","middleName":"","lastName":"Veccia","suffix":""},{"id":585275187,"identity":"3534d542-9fea-49d2-ae4d-8471a5f35592","order_by":2,"name":"Sarah Malandra","email":"","orcid":"","institution":"University of Verona","correspondingAuthor":false,"prefix":"","firstName":"Sarah","middleName":"","lastName":"Malandra","suffix":""},{"id":585275189,"identity":"bc113c3a-6b89-4368-9958-f95827624677","order_by":3,"name":"Vincenzo De Marco","email":"","orcid":"","institution":"Azienda Ospedaliera Universitaria Integrata Verona","correspondingAuthor":false,"prefix":"","firstName":"Vincenzo","middleName":"","lastName":"De Marco","suffix":""},{"id":585275191,"identity":"7e8b1f16-38fe-4de2-a09f-6d027b7ca5e0","order_by":4,"name":"Riccardo Rizzetto","email":"","orcid":"","institution":"Azienda Ospedaliera Universitaria Integrata Verona","correspondingAuthor":false,"prefix":"","firstName":"Riccardo","middleName":"","lastName":"Rizzetto","suffix":""},{"id":585275192,"identity":"fe386f97-bde1-4815-8658-7261d9c6b0ea","order_by":5,"name":"Alessandra Gozzo","email":"","orcid":"","institution":"Azienda Ospedaliera Universitaria Integrata Verona","correspondingAuthor":false,"prefix":"","firstName":"Alessandra","middleName":"","lastName":"Gozzo","suffix":""},{"id":585275193,"identity":"0c465596-8b57-434b-b65f-7d793a14aaa0","order_by":6,"name":"Alberto Bianchi","email":"","orcid":"","institution":"Azienda Ospedaliera Universitaria Integrata Verona","correspondingAuthor":false,"prefix":"","firstName":"Alberto","middleName":"","lastName":"Bianchi","suffix":""},{"id":585275194,"identity":"7dc2e2ae-a17b-4fc0-872b-cd58121d5a2b","order_by":7,"name":"Matteo Brunelli","email":"","orcid":"","institution":"University of Verona","correspondingAuthor":false,"prefix":"","firstName":"Matteo","middleName":"","lastName":"Brunelli","suffix":""},{"id":585275195,"identity":"c1898aee-26e6-4acc-bf83-e78bd90f2acf","order_by":8,"name":"Mairanna Noale","email":"","orcid":"","institution":"Neuroscience Institute","correspondingAuthor":false,"prefix":"","firstName":"Mairanna","middleName":"","lastName":"Noale","suffix":""},{"id":585275196,"identity":"d68bb251-1d0f-49ed-9e6f-c9a247d92858","order_by":9,"name":"Maria Angela Cerruto","email":"","orcid":"","institution":"University of Verona","correspondingAuthor":false,"prefix":"","firstName":"Maria","middleName":"Angela","lastName":"Cerruto","suffix":""},{"id":585275197,"identity":"2507936e-c2ac-4c7d-b0a5-7ae570c187a8","order_by":10,"name":"Riccardo Bertolo","email":"data:image/png;base64,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","orcid":"","institution":"University of Verona","correspondingAuthor":true,"prefix":"","firstName":"Riccardo","middleName":"","lastName":"Bertolo","suffix":""}],"badges":[],"createdAt":"2026-01-28 14:25:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8721999/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8721999/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s11701-026-03260-5","type":"published","date":"2026-03-19T15:59:18+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":101940273,"identity":"1cea68b0-39d6-456c-aa28-65182357a493","added_by":"auto","created_at":"2026-02-05 09:13:30","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1118296,"visible":true,"origin":"","legend":"\u003cp\u003eEstimated and adjusted UCLA-PCI mean scores for the six domains before RARP and at each follow-up time point by robotic platform.\u003c/p\u003e","description":"","filename":"Figure1.linesUCLAPCI5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/163e58c92f19d3869e618fa8.jpg"},{"id":101940313,"identity":"5b355b31-8fd3-4bbe-8f01-a95a7e3f3dab","added_by":"auto","created_at":"2026-02-05 09:13:39","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":1587349,"visible":true,"origin":"","legend":"\u003cp\u003eEstimated and adjusted SF-36 mean scores for the eight domains before RARP and at each follow-up time point by robotic platform.\u003c/p\u003e","description":"","filename":"Figure2.linesSF365.jpg","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/61216a131f206894406a5e11.jpg"},{"id":105223714,"identity":"89ef12c0-b644-43c6-8395-93587d210e5a","added_by":"auto","created_at":"2026-03-23 16:09:17","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":3303271,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/7c2fbe37-2b66-48b9-868f-3e0b998c1ff3.pdf"},{"id":101940296,"identity":"fa58448e-b819-4ab9-94aa-b2f224b68243","added_by":"auto","created_at":"2026-02-05 09:13:37","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":22628,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/e470287adc7dfea2f65e14a6.docx"},{"id":101940317,"identity":"322a53c4-8fd3-4666-a6c4-cc85b6fff5aa","added_by":"auto","created_at":"2026-02-05 09:13:40","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":22806,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable2.docx","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/7454b1c27561b32d3d326ef4.docx"},{"id":101940285,"identity":"965c7dc1-4111-4729-9abc-1e47fe06499b","added_by":"auto","created_at":"2026-02-05 09:13:34","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":35909,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTable3.docx","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/c525b369afec531c2afb4653.docx"},{"id":101940299,"identity":"8d347ccb-4a99-4ffc-8fd7-d4c3dc019187","added_by":"auto","created_at":"2026-02-05 09:13:37","extension":"csv","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":391,"visible":true,"origin":"","legend":"","description":"","filename":"NCT05766163.csv","url":"https://assets-eu.researchsquare.com/files/rs-8721999/v1/d983fbcd857290b1f60bc101.csv"}],"financialInterests":"No competing interests reported.","formattedTitle":"Six-month outcomes of a Three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. Versius robotic radical prostatectomy: (the COMPAR-P trial)","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eIn the past few years, novel robotic platforms have been introduced, potentially increasing competition in the market, lowering the cost of robotics, and potentially expanding the number of patients benefiting from surgery performed via a robotic approach [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA), has long been the gold standard in robotic-assisted surgery, dominating the field with its surgeon-friendly interface. Since its introduction, it has become synonymous with minimally invasive prostatectomy, offering three-dimensional visualization, enhanced dexterity with wristed instruments, and ergonomic control for surgeons.\u003c/p\u003e \u003cp\u003e The Versius (CMR Surgical Ltd, Cambridge, UK) and the Hugo RAS (Medtronic, Minneapolis, MN, USA) systems have emerged as other frontrunners in robotic prostatectomy after receiving the CE mark approval in 2021 and 2019. These platforms introduced novel features such as modular robotic arms and an open console architecture, promising to address eventual limitations associated with Da Vinci [\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThese systems have had a patchy penetration among institutions, so a few publications have appeared, generally represented by retrospective single-arm non-comparative studies [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThere is an imperative need for a comprehensive comparative analysis between the two robotic platforms. Understanding the nuanced differences in efficacy, ergonomics, cost-effectiveness, and learning curves is essential for surgeons, healthcare institutions, and patients.\u003c/p\u003e \u003cp\u003e Accordingly, we promoted a prospective study to perform a head-to-head comparison of the three platforms CE-marked for RARP. The present paper reports granular data of the patients enrolled in the three arms: Da Vinci versus Hugo RAS versus Versius RARP, to compare the postoperative and patient-reported outcomes of the RARP performed with these three platforms.\u003c/p\u003e"},{"header":"2. Materials and Methods","content":"\u003cp\u003eThe COMPAR-P trial (Comparison of Outcomes of Multiple Platforms for Assisted Robotic Surgery - Prostate) is a monocentric, post-market investigation promoted by the Azienda Ospedaliera Universitaria Integrata (A.O.U.I.) of Verona, Italy [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. It secured approval from the local ethical committee (4038CESC) and underwent registration on ClinicalTrials.gov (NCT05766163). The study was performed in accordance with the Declaration of Helsinki.\u003c/p\u003e \u003cp\u003eEnrollment commenced in March 2023. Patients diagnosed with organ-confined prostate\u003c/p\u003e \u003cp\u003ecancer and deemed suitable for RARP at our department were assigned to one of the evaluated\u003c/p\u003e \u003cp\u003eplatforms until cohorts of 50 consecutive cases were completed. Every patient wishing to participate in the study provided signed informed consent.\u003c/p\u003e \u003cp\u003eThe operating room personnel underwent intensive 3-day training at the ORSI Academy in Melle, Belgium. Two console surgeons (AA and VD), with prior experience exceeding 1000 and 500 da Vinci RARP interventions, respectively, conducted all the procedures. Importantly, none had performed any clinical procedure with the Hugo RAS or the Versius platforms before recruitment for this study started. Three additional surgeons, well-versed in robotic assistance (RB, RR, and AV), participated as table assistants. The anesthesiologic protocol and patient positioning (supine position, legs together and extended, 25\u0026deg; Trendelenburg) remained consistent regardless of the platform used.\u003c/p\u003e \u003cp\u003eSpecific adaptations in port placement relative to the Da Vinci system were applied according to the platform used, as previously described [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Consistency was maintained across platforms concerning insufflation and aspiration systems, robotic instruments (monopolar scissor, Maryland bipolar forceps, fenestrated grasp, and needle-driver), assistant instruments, sutures, and clips. The surgical technique was reproduced identically, regardless of the platform used. Depending on clinical data, an intra-, inter-, or extra-fascial anterior antegrade dissection was performed. The decision to perform a lymph-node dissection (LND) was based on the calculated risk of lymph-nodal invasion, determined by nomograms, and followed an extended template [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. The postoperative course was managed following the Institutional standard practice in all cases [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe present study aimed to evaluate, with a 6-month follow-up, the differences among da Vinci vs. Hugo RAS vs. Versius in terms of:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eserum prostate-specific antigen (PSA, considered undetectable when \u0026lt;\u0026thinsp;0.1 ng/mL);\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003epostoperative complications (as classified according to Clavien-Dindo grade, considered as major complications if grade\u0026thinsp;\u0026gt;\u0026thinsp;3);\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003epostoperative sequelae occurring beyond 90 days (monitored up to 180 days postoperatively);\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003epatients\u0026rsquo; health-related quality of life (assessed by administering the Italian-validated versions of the SF-36 and University of California Los Angeles Prostate Cancer Index [UCLA-PCI] questionnaires [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]).\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003cp\u003eDe-identified data were systematically collected in a Research Electronic Data Capture (REDCap)\u003c/p\u003e \u003cp\u003edataset throughout the surgical procedures by an assigned investigator who did not participate\u003c/p\u003e \u003cp\u003ein the surgeries. Access to REDCap was restricted to a specific password-coded computer\u003c/p\u003e \u003cp\u003esecurely stored within a locker. The password underwent periodic changes and was exclusively managed by the involved investigators.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e2.1. Statistical Analysis\u003c/h2\u003e \u003cp\u003eAll statistical analyses were conducted per international guidelines for clinical research reporting [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. The sample size was determined based on study feasibility, resulting in 50 patients per cohort. The distribution of continuous variables was assessed using the Shapiro\u0026ndash;Wilk test and visual inspection (histograms and Q\u0026ndash;Q plots). Normally distributed data were summarized as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (SD), whereas non-normally distributed variables were presented as median and interquartile range (IQR, 25th \u0026minus;\u0026thinsp;75th percentile). Categorical variables were described as counts and percentages. Between-group comparisons were performed using the Student\u0026rsquo;s t-test for normally distributed continuous variables and the Mann\u0026ndash;Whitney U test for nonparametric variables. Differences in categorical variables were analyzed using Pearson\u0026rsquo;s chi-square test or Fisher\u0026rsquo;s exact test when expected counts were \u0026lt;\u0026thinsp;5.\u003c/p\u003e \u003cp\u003eLongitudinal outcomes (SF-36 and UCLA-PCI scores) were analyzed using linear mixed-effects models with random intercepts for patients. Fixed effects included robotic platform, time, and the platform \u0026times; time interaction. Adjustment variables were age at surgery, baseline questionnaire scores, preoperative serum PSA levels, and prostate volume.\u003c/p\u003e \u003cp\u003eMissing data were assumed to be random, and no imputation methods were adopted. The domain scores were calculated excluding the missing items. The domain score was not calculated if more than 50% of the items were missing. All tests were two-sided, with statistical significance set at P\u0026thinsp;\u0026lt;\u0026thinsp;0.05. Analyses were performed using Stata version 18.0 (StataCorp LLC, College Station, TX, USA). Key commands included: swilk, histogram, ttest, tabstat, ranksum, tabulate, chi2, mixed, contrast, and margins.\u003c/p\u003e \u003c/div\u003e"},{"header":"3. Results","content":"\u003cp\u003eDuring the study period, 150 patients were operated on, specifically 50 patients for each platform under investigation. The operated patients\u0026rsquo; baseline demographic and disease characteristics were not statistically different when comparing platform versus platform, respectively [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. The number of patients with a measurable PSA at six-month follow-up after surgery was 2 (4%) in both the Da Vinci and Hugo RAS groups, and 4 (8%) in the Versius group, with no statistically significant differences (\u003cb\u003eSupplementary Table\u0026nbsp;1\u003c/b\u003e).\u003c/p\u003e \u003cp\u003eBoth minor and major complications and postoperative sequelae occurring beyond 90 days after surgery are detailed in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, stratified by platform.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eDetails of Complications, Sequelae, and Management.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cem\u003eDa Vinci\u0026reg;\u003c/em\u003e\u003c/p\u003e \u003cp\u003eNo. events\u0026thinsp;=\u0026thinsp;17\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eEvent\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eDiagnosis time (postoperative days)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003eManagement\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Incisional hernia\u003c/p\u003e \u003cp\u003e2. Edema of the lower limbs\u003c/p\u003e \u003cp\u003e3. Desaturation (90% SpO\u003csub\u003e2\u003c/sub\u003e)\u003c/p\u003e \u003cp\u003e4. Leakage from the vesicourethral anastomosis (4x)\u003c/p\u003e \u003cp\u003e5. Orchiepididymitis (2x)\u003c/p\u003e \u003cp\u003e6. Myocardial Infarction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. No current management; hernia repair may be considered if needed.\u003c/p\u003e \u003cp\u003e2. Wearing compression stockings\u003c/p\u003e \u003cp\u003e3. Chest X-ray performed, and antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e4. Maintenance/repositioning of the urinary catheter\u003c/p\u003e \u003cp\u003e5. antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e6. PTCA\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Orchiepididymitis\u003c/p\u003e \u003cp\u003e2. Incisional hernia (2x)\u003c/p\u003e \u003cp\u003e3. Fluid collection at the midline wound\u003c/p\u003e \u003cp\u003e4. Leakage from the vesicourethral anastomosis (2x)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;30, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 90 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e2. No current management; hernia repair may be considered if needed.\u003c/p\u003e \u003cp\u003e3. Antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e4. Repositioning of the urinary catheter\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Urethral stenosis with retention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;90, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 180 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Placement of suprapubic cystostomy and urethrotomy\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHugo RAS\u0026trade;\u003c/b\u003e\u003c/p\u003e \u003cp\u003eNo. events\u0026thinsp;=\u0026thinsp;18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Urinary retention\u003c/p\u003e \u003cp\u003e2. Peritoneal effusion\u003c/p\u003e \u003cp\u003e3. Pulmonary embolism originating from thrombosis of the left common and deep femoral venous axis\u003c/p\u003e \u003cp\u003e4. Urinary Tract Infection\u003c/p\u003e \u003cp\u003e5. Bilateral orchitis\u003c/p\u003e \u003cp\u003e6. Leakage from the vesicourethral anastomosis with catheterization\u003c/p\u003e \u003cp\u003e7. Abdominal hemorrhage\u003c/p\u003e \u003cp\u003e8. Pulmonary embolism with intensive care unit admission\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Catheterization, antibiotic therapy, and cystography prior to catheter removal\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Penile tumescence\u003c/p\u003e \u003cp\u003e2. Venous ooze from the wound edge\u003c/p\u003e \u003cp\u003e3. Umbilical hernia (2x)\u003c/p\u003e \u003cp\u003e4. Difficulty with adduction of the left thigh\u003c/p\u003e \u003cp\u003e5. Pulmonary embolism originating from thrombosis of the left deep femoral and common femoral veins\u003c/p\u003e \u003cp\u003e6. Recurrent urinary retention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;30, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 90 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Conservative management, with spontaneous resolution\u003c/p\u003e \u003cp\u003e2. Suture placed after local anesthetic spray\u003c/p\u003e \u003cp\u003e3. No current management; hernia repair may be considered if needed.\u003c/p\u003e \u003cp\u003e4. Electromyography performed: finding of chronic axonal injury of the left obturator nerve: on neurological indication, physiotherapy initiated.\u003c/p\u003e \u003cp\u003e5. Rivaroxaban initiated\u003c/p\u003e \u003cp\u003e6. Cystography and flexible urethrocystoscopy performed; catheter replaced\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Lymphocele\u003c/p\u003e \u003cp\u003e2. Lymphedema of the right lower limb, involving the inguinal region\u003c/p\u003e \u003cp\u003e3. Recurrent urinary retention\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;90, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 180 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Conservative management\u003c/p\u003e \u003cp\u003e2. Lymphatic drainage massages performed\u003c/p\u003e \u003cp\u003e3. Cystography and flexible urethrocystoscopy performed; catheter replaced\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eVersius\u0026reg;\u003c/b\u003e\u003c/p\u003e \u003cp\u003enumber of events\u0026thinsp;=\u0026thinsp;24\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Urinary tract infection\u003c/p\u003e \u003cp\u003e2. Hematuria and pelvic pain in the absence of fever; tenderness at the perineum and right hemiscrotum; right epididymis slightly tender, likely reflecting inflammatory sequelae\u003c/p\u003e \u003cp\u003e3. Findings of scrotal edema, pollakiuria, and dysuria\u003c/p\u003e \u003cp\u003e4. Leakage from the vesicourethral anastomosis (2x)\u003c/p\u003e \u003cp\u003e5. Abdominal pain\u003c/p\u003e \u003cp\u003e6. Urosepsis\u003c/p\u003e \u003cp\u003e7. Fever (urine and blood cultures negative)\u003c/p\u003e \u003cp\u003e8. Abdominal distension (globular, non-tender abdomen), mild tenderness in the right flank.\u003c/p\u003e \u003cp\u003e9. Scrotal edema\u003c/p\u003e \u003cp\u003e10. Initial lymphedema of the right lower limb, involving the inguinal region\u003c/p\u003e \u003cp\u003e11. Pain localized to the perineum in the seated position\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e\u0026thinsp;30 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e2. Started dietary supplement containing bromelain, papain, and fungal proteases\u003c/p\u003e \u003cp\u003e3. Urine culture showed no growth. Conservative management\u003c/p\u003e \u003cp\u003e4. Maintenance/repositioning of the urinary catheter\u003c/p\u003e \u003cp\u003e5. Analgesics initiated\u003c/p\u003e \u003cp\u003e6. Antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e7. Antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e8. Conservative management\u003c/p\u003e \u003cp\u003e9. Conservative management, with spontaneous resolution\u003c/p\u003e \u003cp\u003e10. Lymphatic drainage massages performed\u003c/p\u003e \u003cp\u003e11. Local ice therapy applied\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Urinary tract infection (3x)\u003c/p\u003e \u003cp\u003e2. Penile tumescence\u003c/p\u003e \u003cp\u003e3. Persistent pain symptoms at the level of the coccyx, perineal area, and penile shaft.\u003c/p\u003e \u003cp\u003e4. Dysuria\u003c/p\u003e \u003cp\u003e5. Lower urinary tract symptoms with weak stream, urinary urgency, and urge incontinence\u003c/p\u003e \u003cp\u003e6. Lymphocele\u003c/p\u003e \u003cp\u003e7. Severe erectile dysfunction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;30, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 90 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Antibiotic therapy initiated\u003c/p\u003e \u003cp\u003e2. Conservative management, with spontaneous resolution\u003c/p\u003e \u003cp\u003e3. Coccygeal massages of limited success; use of analgesic\u003c/p\u003e \u003cp\u003e4. Cystography and flexible urethrocystoscopy with diagnosis of anastomosis stricture\u003c/p\u003e \u003cp\u003e5. Negative urine culture. Urodynamic diagnosis of hypocontractile and overactive bladder\u003c/p\u003e \u003cp\u003e6. Conservative management\u003c/p\u003e \u003cp\u003e7. penile doppler ultrasound: hemodynamic parameters consistent with erectile dysfunction due to veno-occlusive dysfunction\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e1. Acute urinary retention associated with pain and vomiting\u003c/p\u003e \u003cp\u003e2. Dysuria\u003c/p\u003e \u003cp\u003e3. Lymphedema of the right lower limb\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u0026gt;\u0026thinsp;90, \u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026le;\u003c/span\u003e 180 days\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1. Placement of suprapubic cystostomy\u003c/p\u003e \u003cp\u003e2. Endoscopic management of a diagnosed stenosis of the vesicoureteral anastomosis.\u003c/p\u003e \u003cp\u003e3. Wearing compression stockings\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eAll patients completed the SF-36 and UCLA-PCI questionnaires at baseline (response rate 100%).\u003c/p\u003e \u003cp\u003e \u003cb\u003eSupplementary Table\u0026nbsp;2\u003c/b\u003e includes the questionnaire scores at baseline, derived from the patients\u0026rsquo; raw responses, before applying the statistical model.\u003c/p\u003e \u003cp\u003eFor Da Vinci, Hugo RAS, and Versius, the response rates were 100, 92, and 98% at 1-month follow-up, 98, 98, and 94% at 3 months, and 100, 94, and 94% at the 6-month monitoring visit, respectively.\u003c/p\u003e \u003cp\u003eThe effects of the type of robot used (Da Vinci, Hugo RAS, Versius) on the 0\u0026ndash;100 response scores of the SF-36 and UCLA-PCI questionnaires at different study time points (baseline/surgery time, follow-up at 1, 3, and 6 months) were analyzed using a mixed model with robot \u0026times; time interaction (detailed in \u003cb\u003eSupplementary Table\u0026nbsp;3\u003c/b\u003e). Comparisons between robotic groups at each time point did not show statistically significant differences for most domains analyzed (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). However, the interaction analysis revealed some significant effects: on the UCLA-PCI questionnaire, the Hugo RAS group showed a mean difference of \u0026minus;\u0026thinsp;19.73 points (p\u0026thinsp;=\u0026thinsp;0.03, 95% CI [\u0026ndash;37.53; \u0026minus;\u0026thinsp;1.93]), indicating a significant reduction in the Sexual Function domain score compared with the Da Vinci group. The Versius group also showed a significant mean decrease of \u0026minus;\u0026thinsp;27.7 points (p\u0026thinsp;=\u0026thinsp;0.001, 95% CI [\u0026ndash;43.51; \u0026minus;\u0026thinsp;11.88]) in the Sexual Function score compared with the Da Vinci group at 1-month post-surgery. Finally, again at 1 month postoperatively, the Versius group showed a mean difference of \u0026minus;\u0026thinsp;25.16 points (p\u0026thinsp;=\u0026thinsp;0.026, 95% CI [\u0026ndash;47.35; \u0026minus;\u0026thinsp;2.97]), suggesting a significant reduction in the Sexual Bother domain score compared with the Da Vinci group.\u003c/p\u003e \u003cp\u003eAs for the SF-36 questionnaire, the only significant difference was observed in the Physical Functioning domain, where Hugo RAS, at 1-month post-surgery, showed an average score of +\u0026thinsp;17.10 points higher compared with the Da Vinci group (Graphical representations are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eWith the growing diversification of the global surgical robotics ecosystem, multiple platforms are becoming increasingly common. This raises the question of whether these systems differ in performance and cost.\u003c/p\u003e \u003cp\u003eSeveral comparative studies have addressed this issue, but most available evidence is retrospective and of low quality. While some systematic reviews have attempted to synthesize the data, significant heterogeneity limits the strength of their conclusions [\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. These reviews suggest that the platforms are broadly comparable regarding safety, functional outcomes, and oncologic efficacy in cancer surgery.\u003c/p\u003e \u003cp\u003eTo our knowledge, ours is the first prospective study to compare robotic prostatectomy across three platforms: Da Vinci Xi, Hugo RAS, and Versius.\u003c/p\u003e \u003cp\u003eIn the context of an oncological surgical intervention, such as RARP, it is reassuring that\u0026mdash;despite the relatively small sample size and limited follow-up\u0026mdash;no significant differences were observed between patients operated with different robotic platforms regarding postoperative PSA. Six months after surgery, most patients had undetectable PSA values, regardless of the platform used, suggesting that the oncological safety of the procedure is preserved across technologies.\u003c/p\u003e \u003cp\u003eMost complications were minor and captured within the hyper-controlled trial setting. Interesting in the present work is the description of late postoperative sequelae, recorded between 90 days and the 6-month follow-up visit. These events were anecdotal in nature and comparable across platforms.\u003c/p\u003e \u003cp\u003ePerhaps the most relevant findings come from the analysis of patient-reported outcomes. One of the main strengths of this prospective study lies in the granularity of adverse event reporting, both in the early and mid-term, but especially in the systematic collection of validated questionnaires. While radical prostatectomy is effective for cancer control, it is often associated with quality-of-life issues related to erectile dysfunction and urinary incontinence. Therefore, integrating patient-reported outcomes into clinical care is crucial to ensure comprehensive and effective treatment [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe response rate of our investigation was remarkably high, exceeding 90% and often approaching 100% at all evaluated time points, providing robustness to these results.\u003c/p\u003e \u003cp\u003eFrom a global perspective, comparisons between robotic systems did not reveal significant differences in most questionnaire domains. However, some differences emerged when focusing on specific outcomes at the 1-month time point. On the UCLA-PCI questionnaire, the Hugo RAS (\u0026ndash;20 points) and the Versius platform (\u0026ndash;28 points) showed a significant reduction in the Sexual Function domain compared with Da Vinci. In the Sexual Bother domain, Versius also performed worse than Da Vinci (\u0026ndash;25 points). The fact that Versius performed worse in the immediate postoperative period in terms of perceived sexual function contrasts, to some extent, with the high rate of positive surgical margins (40%), with a p-value approaching significance not in comparison with Da Vinci, but rather with Hugo RAS. Although baseline disease characteristics did not differ between groups, and nerve-sparing techniques were applied with comparable frequency across platforms, there may be something intrinsic to the console vision that could influence dissection. While this cannot be stated with certainty based on our data, it is certainly a finding that cannot be overlooked. That said, this difference in margin status did not translate into variations in the proportion of patients achieving undetectable PSA during follow-up. On the other hand, it is essential to underline that these differences were limited to the 1-month follow-up and disappeared at subsequent 3- and 6-month evaluations, suggesting only a transient early effect.\u003c/p\u003e \u003cp\u003eOn the SF-36 questionnaire, the only significant difference was observed in the Physical Functioning domain, where Hugo RAS patients scored on average 17 points higher than Da Vinci patients at 1 month. While this result is more difficult to interpret, one possible explanation may relate to differences in ergonomics, port placement, or convalescence dynamics, which could have temporarily influenced patients\u0026rsquo; perceived ability to perform daily activities. We cannot comment on this further. Once again, however, these differences resolved at later follow-ups, reinforcing the notion of equivalence in the medium term. Moreover, although some estimates showed numerically potentially relevant differences, the wide confidence intervals suggest that the study may be underpowered to detect significant differences. Further analyses with larger samples may be needed to confirm these trends.\u003c/p\u003e \u003cp\u003eOverall, compared with previously published experiences that have focused mainly on perioperative aspects such as docking time or operative duration [\u003cspan additionalcitationids=\"CR3\" citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], our study provides a broader and more detailed picture. Data collection was prospective, with balanced cohorts and without patient selection, and follow-up was particularly rigorous, extending to 6 months.\u003c/p\u003e \u003cp\u003eThe findings support the conclusion that robotic platforms are equivalent in terms of both safety (comparable complication profiles) and oncological efficacy (as indicated by undetectable PSA rates). Ultimately, our results reinforce the notion that surgical outcomes depend less on the type of robotic system used and more on the surgeon\u0026rsquo;s expertise and technique [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Notably, the procedures in this study were performed by high-volume robotic surgeons with extensive Da Vinci experience, who nonetheless achieved comparable results already within their first 50 cases using the alternative platforms [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAmong the multitude of data analyzed, the only signal suggesting a potential \u0026ldquo;inferiority\u0026rdquo; of Hugo RAS and Versius concerned early patient-reported sexual function. However, given that these differences were limited to the first postoperative month and no longer evident by 3 and 6 months, their clinical significance remains debatable. A plausible interpretation is that the Da Vinci platform may initially allow more refined nerve-sparing, possibly because surgeons are more familiar with its instrumentation and energy settings, thereby reducing the risk of injury to the neurovascular bundles\u0026mdash;although this remains only a hypothesis. Over time, recovery mitigates these differences.\u003c/p\u003e \u003cp\u003eIn summary, this prospective study demonstrates that different robotic platforms can achieve equivalent results in terms of oncological efficacy, safety, and medium-term patient-reported outcomes. The transient differences observed in some functional domains at 1 month should be interpreted with caution, and further long-term and multicenter data will be valuable to confirm these findings.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflicts of interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors certify that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFundings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRegione Veneto (CriTE) – 21/09/2022 rif. 434224 (prot. Gen. 56613/2022).\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e§\u003c/sup\u003e\u003cstrong\u003eList of Contributors\u003c/strong\u003e: University of Verona Residency Program in Urology\u003c/p\u003e\n\u003cp\u003eMariana Finocchiaro, Luca Rahmati, Mattia Ronca, Michele\u0026nbsp;Aloe, Peres Fokana Pongmoni, Andrea Franceschini, Antonio Raiti, Endri Toska, Vincenzo Vetro, Francesco Artoni, Alberto Baielli, Claudio Brancelli, Sonia Costantino, Piero Fracasso, Francesca Fumanelli, Francesca Montanaro, Iolanda Palumbo, Greta Pattenuzzo, Luca Roggero, Michele Boldini, Davide Brusa, Giovanni Corghi, Lorenzo De Bon, Francesco Ditonno, Lorenzo Pierangelo Treccani\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eFarinha R, Puliatti S, Mazzone E, et al. Potential contenders for the leadership in robotic surgery. J Endourol 2022;36:317\u0026ndash;26. https://doi.org/10.1089/end.2021.0321.\u003c/li\u003e\n\u003cli\u003eFicarra V, Rossanese M, Giannarini G, Longo N, Vigan\u0026ograve; S, Russo D, Sorce G, Simonato A, Bartoletti R, Crestani A, Di Trapani E. Evaluation of Clinical Research on Novel Multiport Robotic Platforms for Urological Surgery According to the IDEAL Framework: A Systematic Review of the Literature. Eur Urol Open Sci. 2024 Jul 18;67:7-25. doi: 10.1016/j.euros.2024.06.014. \u003c/li\u003e\n\u003cli\u003eLeang YJ, Kong JCH, Mosharaf Z, Hensman CS, Burton PR, Brown WA. Emerging multi-port soft tissue robotic systems: a systematic review of clinical outcomes. J Robot Surg. 2024 Mar 30;18(1):145. doi: 10.1007/s11701-024-01887-w. \u003c/li\u003e\n\u003cli\u003eReitano G, Tumminello A, Ghaffar U, Saggionetto G, Taverna A, Mangiacavallo F, Ahmed ME, Basourakos SP, Carletti F, Minardi D, Iafrate M, Morlacco A, Betto G, Karnes RJ, Moro FD, Zattoni F, Novara G. Perioperative, Oncological, and Functional Outcomes of New Multiport Robotic Platforms in Urology: A Systematic Review and Meta-analysis. Eur Urol Open Sci. 2025 Mar 3;74:44-70. doi: 10.1016/j.euros.2025.02.003.\u003c/li\u003e\n\u003cli\u003eSalkowski M, Checcucci E, Chow AK, Rogers CC, Adbollah F, Liatsikos E, Dasgupta P, Guimaraes GC, Rassweiler J, Mottrie A, Breda A, Crivellaro S, Kaouk J, Porpiglia F, Autorino R. New multiport robotic surgical systems: a comprehensive literature review of clinical outcomes in urology. Ther Adv Urol. 2023 Jun 5;15:17562872231177781. doi: 10.1177/17562872231177781.\u003c/li\u003e\n\u003cli\u003eVeccia A, Malandra S, Montanaro F, Pettenuzzo G, Bravi CM, Caslini VV, \u003cem\u003eet al. \u003c/em\u003eComparison of outcomes of multiple platforms for assisted robotic-prostatectomy: rationale and design. Minerva Urol Nephrol 2023;75:540\u0026ndash;2.\u003c/li\u003e\n\u003cli\u003eAntonelli A, Veccia A, Malandra S, Rizzetto R, De Marco V, Baielli A, Franceschini A, Fumanelli F, Montanaro F, Palumbo I, Pettenuzzo G, Roggero L, Angela Cerruto M, Bertolo R; Collaborators. Intraoperative Performance of DaVinci Versus Hugo RAS During Radical Prostatectomy: Focus on Timing, Malfunctioning, Complications, and User Satisfaction in 100 Consecutive Cases (the COMPAR-P Trial). Eur Urol Open Sci. 2024 Apr 4;63:104-112. doi: 10.1016/j.euros.2024.03.013.\u003c/li\u003e\n\u003cli\u003eAntonelli A, Veccia A, Malandra S, Rizzetto R, Bianchi A, Franceschini A, et al. First prospective comparison between Versius and DaVinci Xi for robotic radical prostatectomy: focus on operative room setup, surgical timing, troubleshooting, and surgeon satisfaction (COMPAR-P Trial). Minerva Urol Nephrol. 2025 Oct;77(5):655-663. doi: 10.23736/S2724-6051.25.06514-0. \u003c/li\u003e\n\u003cli\u003ehttps://uroweb.org/guidelines/prostate-cancer Last access on Sept 16\u003csup\u003eth\u003c/sup\u003e 2025.\u003c/li\u003e\n\u003cli\u003eApolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol 1998;51:1025\u0026ndash;36.\u003c/li\u003e\n\u003cli\u003eGacci M, Livi L, Paiar F, Detti B, Litwin MS, Bartoletti R, \u003cem\u003eet al. \u003c/em\u003eQuality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index. Urology 2005;66:338\u0026ndash;43. \u003c/li\u003e\n\u003cli\u003eAssel M, Sjoberg D, Elders A, et al. Guidelines for reporting of statistics for clinical research in urology. BJU Int 2019; 123: 401-10.\u003c/li\u003e\n\u003cli\u003ePal A, Gamage R. Robotic abdominopelvic surgery: a systematic review of cross-platform outcomes. J Robot Surg. 2024 Oct 29;18(1):386. doi: 10.1007/s11701-024-02144-w.\u003c/li\u003e\n\u003cli\u003eBakalis VI. Evaluating Quality of Life of Prostate Cancer Patients After Radical Prostatectomy. Cureus. 2025 Mar 3;17(3):e79973. doi: 10.7759/cureus.79973.\u003c/li\u003e\n\u003cli\u003eDitonno F, Pettenuzzo G, Montanaro F, De Bon L, Costantino S, Toska E, et al. Head-to-head comparison of DaVinci and Hugo\u0026trade; RAS robotic platforms for robot-assisted radical prostatectomy: a systematic review and meta-analysis of comparative studies. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):309-317. doi: 10.1038/s41391-024-00908-x. Epub 2024 Oct 15. \u003c/li\u003e\n\u003cli\u003eStuder UE. The surgeon makes the difference, not the instrument used. Eur Urol 2015;67:1051\u0026ndash;2.\u003c/li\u003e\n\u003cli\u003eAntonelli A, Veccia A, Malandra S, Rizzetto R, Artoni F, Fracasso P, Fumanelli F, Palumbo I, Raiti A, Roggero L, Treccani LP, Vetro V, DE Marco V, Porcaro AB, Cerruto MA, Brunelli M, Bertolo R; Residency Program in Urology at the University of Verona. Outcomes of da Vinci\u0026reg; versus Hugo RAS\u0026reg; radical prostatectomy: focus on postoperative course, pathological findings, and patients\u0026apos; health-related quality of life after 100 consecutive cases (the COMPAR-P prospective trial). Minerva Urol Nephrol. 2024 Oct;76(5):596-605. doi: 10.23736/S2724-6051.24.05928-7.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-robotic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jors","sideBox":"Learn more about [Journal of Robotic Surgery](http://link.springer.com/journal/11701)","snPcode":"11701","submissionUrl":"https://submission.nature.com/new-submission/11701/3","title":"Journal of Robotic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"DaVinci, Hugo RAS, Versius, Radical prostatectomy, Robotic surgery","lastPublishedDoi":"10.21203/rs.3.rs-8721999/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8721999/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eTo compare postoperative, oncological, and patient-reported outcomes of robot-assisted radical prostatectomy (RARP) performed with three CE-marked robotic platforms: Da Vinci Xi, Hugo RAS, and Versius.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe COMPAR-P trial is a prospective, monocentric, post-market study conducted at the Azienda Ospedaliera Universitaria Integrata of Verona, Italy (ClinicalTrials.gov NCT05766163). From March 2023, 150 patients with organ-confined prostate cancer were consecutively enrolled and allocated to undergo RARP with Da Vinci Xi (n\u0026thinsp;=\u0026thinsp;50), Hugo RAS (n\u0026thinsp;=\u0026thinsp;50), or Versius (n\u0026thinsp;=\u0026thinsp;50). Two high-volume robotic surgeons performed all procedures, experienced with Da Vinci but na\u0026iuml;ve to Hugo RAS and Versius before trial initiation. Surgical technique, perioperative protocols, and follow-up were standardized across cohorts. Outcomes at 6 months included serum PSA, complications (Clavien\u0026ndash;Dindo classification), late sequelae (\u0026gt;\u0026thinsp;90 days), and health-related quality of life (SF-36 and UCLA-PCI questionnaires). Longitudinal analyses used linear mixed-effects models.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eBaseline demographics and disease characteristics were comparable across groups. At 6 months, PSA was undetectable in most patients, with no significant intergroup differences. Complication rates and late sequelae were low and evenly distributed. Questionnaire completion exceeded 90% at all time points. No significant long-term differences emerged in most SF-36 and UCLA-PCI domains. However, at 1 month, Hugo RAS and Versius patients reported lower Sexual Function scores than Da Vinci (\u0026ndash;20 and \u0026minus;\u0026thinsp;28 points, respectively), and Versius patients reported lower Sexual Bother scores (\u0026ndash;25 points, all p\u0026thinsp;\u0026lt;\u0026thinsp;0.05). These differences disappeared at 3 and 6 months. Hugo RAS patients showed a temporary advantage in Physical Functioning at 1 month (+\u0026thinsp;17 points vs Da Vinci).\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusions:\u003c/b\u003e\u003c/p\u003e \u003cp\u003eDa Vinci, Hugo RAS, and Versius showed equivalent safety, oncological outcomes, and medium-term patient-reported results in RARP. Early functional differences were transient and resolved over time. Surgical expertise, rather than the type of platform, appears to be the primary determinant of outcomes.\u003c/p\u003e","manuscriptTitle":"Six-month outcomes of a Three-arm prospective study comparing Da Vinci vs. Hugo RAS vs. Versius robotic radical prostatectomy: (the COMPAR-P trial)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-05 09:11:42","doi":"10.21203/rs.3.rs-8721999/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-02-05T02:57:22+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"89336372291795239298065219061700856436","date":"2026-02-05T02:04:31+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-04T20:44:10+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-04T15:47:51+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"300290228102881811489316500013210730275","date":"2026-02-04T15:37:46+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-03T20:31:23+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"271238438551727619887404094640140212249","date":"2026-02-03T20:18:39+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"208208337304149678361377639957731044533","date":"2026-02-03T05:51:33+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"15616358210609757099913070300925999590","date":"2026-02-03T04:37:27+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"232564011820063441473584672157190508801","date":"2026-02-03T02:46:20+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-02-03T01:22:15+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-30T13:48:27+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-30T05:18:07+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Robotic Surgery","date":"2026-01-28T13:09:27+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-robotic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jors","sideBox":"Learn more about [Journal of Robotic Surgery](http://link.springer.com/journal/11701)","snPcode":"11701","submissionUrl":"https://submission.nature.com/new-submission/11701/3","title":"Journal of Robotic Surgery","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"af5feea0-0e67-4896-a5fa-1e4a80b416ef","owner":[],"postedDate":"February 5th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-23T16:06:20+00:00","versionOfRecord":{"articleIdentity":"rs-8721999","link":"https://doi.org/10.1007/s11701-026-03260-5","journal":{"identity":"journal-of-robotic-surgery","isVorOnly":false,"title":"Journal of Robotic Surgery"},"publishedOn":"2026-03-19 15:59:18","publishedOnDateReadable":"March 19th, 2026"},"versionCreatedAt":"2026-02-05 09:11:42","video":"","vorDoi":"10.1007/s11701-026-03260-5","vorDoiUrl":"https://doi.org/10.1007/s11701-026-03260-5","workflowStages":[]},"version":"v1","identity":"rs-8721999","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8721999","identity":"rs-8721999","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}

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